Dexamethasone phosphate for Knee arthroscopy

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Undergoing knee arthroscopy lasting ≤ 40 minutes requiring spinal anesthesia (diagnostic arthroscopy or meniscal surgery)\n- Signed written informed consent form\n- Affiliation to a social security system\n- Negative pregnancy test on the day of procedure for non-menopausal patients"}

Exclusion criteria

• {"criterion_text":"- Contraindications to spinal anesthesia with intrathecal chloroprocaine including: hypersensitivity to chloroprocaine, medicinal products of the para-aminobenzoic acid (PABA) ester group, to other ester-type local anesthetics, or to any of the excipients; general and specific contraindications to spinal anesthesia regardless of the local anesthetic used (e.g. decompensated cardiac insufficiency, hypovolemic shock, severe hypovolemia, coagulopathy); intravenous regional anesthesia; serious problems with cardiac conduction; severe anemia; local infection at the puncture site or systemic infection/sepsis\n- Contraindications to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (Ketoprofen, Celecoxib) including: history of hypersensitivity reactions after administration of ketoprofen, celecoxib, aspirin or other NSAIDs (including bronchospasm/asthma, rhinitis, urticaria, angioedema, anaphylaxis); active peptic ulcer disease or active gastrointestinal bleeding; history of recurrent peptic ulcer/hemorrhage; history of gastrointestinal bleeding/ulceration/perforation related to NSAID therapy; severe renal impairment; severe hepatic impairment; severe heart failure; and for celecoxib specifically: known hypersensitivity to sulfonamides; established ischemic heart disease and/or peripheral arterial disease and/or cerebrovascular disease\n- Need for a peripheral nerve block in addition to spinal anesthesia (e.g. knee ligamentoplasty)\n- Mental or linguistic inability to understand the study\n- Patients under legal protection (guardianship, curatorship or safeguard of justice)\n- Patients currently included or planning to be included in another interventional study\n- Pregnant or breastfeeding women\n- Women of childbearing potential not using effective contraception\n- History of diabetes\n- Pre-existing peripheral neuropathy\n- American Society of Anesthesiologists (ASA) physical status IV\n- Contraindication to dexamethasone including: hypersensitivity to dexamethasone or to any of the excipients; systemic infection; systemic fungal infection; administration of live virus vaccines\n- Hypersensitivity of any drug used in this study\n- Long-term oral corticosteroid therapy\n- Chronic opioid use\n- Chronic pain syndromes"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the time to regression of sensory block by two dermatomes, defined as the time (in minutes) from the spinal puncture to the regression of two dermatomes from the highest dermatome level of sensory block achieved after the puncture. Sensory block will be assessed every 5 minutes after spinal puncture using a pin-prick test (0-2: 0 = absent sensation; 1 = dull, decreased sensation; 2 = sharp, normal sensation).","definition_or_measurement_approach":"Time (minutes) from spinal puncture to regression of two dermatomes from highest dermatome level; sensory block assessed every 5 minutes post-puncture using pin-prick test (score 0–2 as defined)."}

Secondary endpoints

• {"endpoint_text":"- Time (in minutes) from the spinal puncture to complete recovery of motor block, assessed by the Modified Bromage Scale (0–3: 0 = full flexion of hip, knee, and ankle; 1 = inability to raise extended leg; 2 = inability to flex knee; 3 = no movement of hip, knee, or ankle). Motor block will be assessed every 5 minutes after the spinal puncture until regression of the sensory block by two dermatomes, and then every 10 minutes until complete motor recovery (Bromage 0).","definition_or_measurement_approach":"Time (minutes) from puncture to Bromage 0; assessed every 5 minutes until sensory regression by two dermatomes, then every 10 minutes until motor recovery."}
• {"endpoint_text":"- Time (in minutes) from the spinal puncture to regression of four dermatomes from the highest dermatome level of sensory block achieved after the puncture. Sensory block will be assessed using the pin-prick test every 5 minutes after the spinal puncture until regression by two dermatomes, and then every 10 minutes until regression by four dermatomes.","definition_or_measurement_approach":"Time (minutes) from puncture to regression by four dermatomes; pin-prick testing schedule as described."}
• {"endpoint_text":"- Highest dermatome level of sensory block achieved after the spinal puncture assessed using the pin-prick test.","definition_or_measurement_approach":"Highest dermatome level determined by pin-prick test."}
• {"endpoint_text":"- Time (in minutes) from the spinal puncture to the highest blocked dermatome.","definition_or_measurement_approach":"Time (minutes) from puncture to attainment of highest sensory block level."}
• {"endpoint_text":"- Need (or not) for an additional anesthetic procedure (sedation or general anesthesia) will be recorded only in the case of intraoperative pain at the incision site, during surgical manipulation, or during tourniquet inflation. Such cases will be considered as failures of spinal anesthesia. If sedation is administered solely for anxiety in the operating room, preventing further sensory or motor assessment, the patient will be excluded from the per-protocol analysis.","definition_or_measurement_approach":"Record requirement for additional anesthetic procedure intraoperatively as failure of spinal anesthesia; exclude specific sedation-only cases from per-protocol analysis."}
• {"endpoint_text":"- Time (in minutes) from the spinal puncture to regression of two dermatomes from the highest dermatome level of sensory block achieved after the puncture, assessed using the cold test. Cold sensation will be evaluated with a stainless-steel cylinder (2–4 °C). The cylinder will be applied gently for 1–2 seconds to each dermatome without pressure. The reference area (T4) will be used to define normal cold sensation.","definition_or_measurement_approach":"Time (minutes) from puncture to regression by two dermatomes assessed by cold test using cooled stainless-steel cylinder as described."}
• {"endpoint_text":"- Any episode occurring from spinal puncture up to 24 hours after surgery, including: hypotension, bradycardia, nausea and vomiting, pruritus, urinary retention.","definition_or_measurement_approach":"Capture any listed events from puncture to 24 hours post-surgery."}
• {"endpoint_text":"- Maximal pain score collected in the PACU using a Numeric Rating Scale (NRS-Pain) ranging from 0 to 10 (0= no pain; 10= extreme pain).","definition_or_measurement_approach":"Maximum NRS pain (0–10) in PACU."}
• {"endpoint_text":"- Total opioid consumption will be recorded and converted to oral morphine equivalents (OME, mg), including all opioids administered during the intraoperative period, in the PACU, during the ambulatory hospitalization until discharge, as well as those taken at home within 24 hours after surgery, as reported during the follow-up phone call at Day 1 (D1).","definition_or_measurement_approach":"Total opioids converted to oral morphine equivalents (mg) across perioperative and first 24 hours post-op including reported home use at D1 follow-up call."}
• {"endpoint_text":"- Pain intensity will be assessed using a Numeric Rating Scale (NRS, 0–10) at rest and during movement, and recorded during the intraoperative period (H0), in the PACU (H1 ± 30min), during the ambulatory hospitalization until discharge (H3 ± 1h and H6 ± 2h), and at home until D1 (H9 ± 2h, H12 ± 2h and H24 ± 3h).","definition_or_measurement_approach":"NRS assessments at specified timepoints: H0, H1 ±30min, H3 ±1h, H6 ±2h, H9 ±2h, H12 ±2h, H24 ±3h."}
• {"endpoint_text":"- Time (in minutes) between the skin incision and the last suture.","definition_or_measurement_approach":"Duration of surgery measured in minutes between incision and last suture."}
• {"endpoint_text":"- Post puncture headache (Yes/No) evaluated at D1.","definition_or_measurement_approach":"Binary assessment (Yes/No) of post-puncture headache at Day 1."}

France

Earliest CTIS Part Ii Submission Date

12-03-2026

Latest Decision Or Authorization Date

08-04-2026

Processing Time Days

27

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Centre Medico Chirurgical Ambroise Pare Hartmann

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France